PVASC Specialist I

Job Purpose:

The key purpose of this role is to support Pharmacovigilance Operations PV Ops – PVASC (Pharmacovigilance Agreements and Safety Clauses) team.

The position holder is responsible for alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PVASC operation activities.

The essence of PVASC Specialist I is to work with a reasonable level of independence to achieve one or more of the Key Responsibilities mentioned below.

Key Responsibilities :

• Good knowledge in monitoring compliance by GSK and Third Parties with PVASC by carrying out routine reconciliations and compliance checks and communicating standard information to Third Parties as required with appropriate guidance.
• Good knowledge in monitoring compliance with regulatory and internal quality of global adverse event reporting. This can include performing Quality Assurance assessments of adverse event reports entered in the GSK global safety database. Role will work on this task, identifying and escalating findings and issues as required with supervision from senior staff.
• Good knowledge in maintenance of information in the pharmacovigilance database, Electronic Data Management System (EDMS), PVASC website pages and shared areas including routine maintenance and documenting information as requested.
• Good knowledge in collection, evaluation, analysis, and documentation of information received from local operating company safety departments.
• Good knowledge in running standard listings from databases as required.
• Good knowledge to administer document storage and archiving including team site per the approved processes.
• Represents during both external regulatory inspection and GSK audits of Third Parties with supervision from senior staff.
• Provides inputs, to and maintain guidance documents and SOPs.
• Can interact with colleagues in SERMs, Business Development, Operating Companies, and external companies as necessary with supervision from senior staff.

Education Requirements ​:

Bachelor/master's degree (scientific or medically related field is preferred) with a minimum of 4-9 years in the pharmaceutical industry in clinical development, pharmacovigilance and information management or equivalent work experience.

Job Related Experience:

·Good knowledge of data collection and interpretation.  

Good ARGUS database search skills.

Other Job-Related Skills:

·Good oral and written communication skills.

·Good computer skills including Word, Excel, PowerPoint, and SharePoint.

·Ability to work with tight deadlines while under pressure; demonstrates planning and organizational skills.

·Results driven with a sense of urgency that ensures timelines within personal control are met.

·Good judgement, common sense, and pragmatism.

·Functions as a team player.

·Ability to work independently.

·Able to build and maintain relationships outside of functional area.

·Proactive problem identification.

·Bridges personal, business, and cultural differences to work effectively in team settings.

·Good in stakeholder management and customer focus.

Develops self

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.